NG11

Prevention Of Radiation-induced Oral Mucositis (RIOM)

Status: Phase II Start Planned For 2021

Oral mucositis is a major, acute complication of radiotherapy and chemotherapy.

Radiation-induced oral mucositis (RIOM) is a well-described, debilitating toxicity affecting up to 80% of Head and Neck Cancer patients treated with radiotherapy. An estimated 56% of patients with RIOM develop a severe form of the complication.

Approximately 95,000 Head and Neck Cancer patients in the US are at risk of developing RIOM every year (VasoDynamics estimate based on published sources).

RIOM starts as an acute inflammation of the mouth, tongue and pharynx mucosa, followed by multiple erosions as a result of epithelial and basement membrane damage.

Symptoms include oral pain and swallowing difficulty leading to weight loss and frequent opioid use (>50% of patients): 70% of patients with WHO Grade 3-4 RIOM require a feeding tube.

RIOM represents a major clinical challenge, including radiation-dose limitations and changes in the dose fractionation protocol (with a potential negative impact on treatment outcomes) coupled with a dramatic, negative effect on the patient’s quality of life.

RIOM is associated with significant additional healthcare cost, estimated at $17,000 per patient with Head & Neck Cancer.

Current therapy is palliative (dietary change, pain relief medication and oral care) and no topical preventative therapy currently exists.